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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The objective of this exploratory pharmacokinetic research study is to demonstrate that both caplets and gummies provide an effective dose of ascorbic acid in healthy adults.
This randomized, examiner-blind, cross-over study evaluates the bioequivalence of a gummy containing vitamin C relative to a caplet comparator product in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C gummy, Then Vitamin C Caplet | Other | The study consisted of two single-day study periods separated by a 7-day washout. At the first study day, a single oral dose of vitamin C gummy (1007.2mg) was orally administered following a 12 hour fasting period. After a 7 day washout period, a single oral dose of vitamin C caplet (1027.9mg) was orally administered following a 12 hour fasting period. |
|
| Vitamin C tablet, Then Vitamin C gummy | Other | The study consisted of two single-day study periods separated by a 7-day washout. At the first study day, a single oral dose of vitamin C caplet (1027.9mg) was orally administered following a 12 hour fasting period. After a 7 day washout period, a single oral dose of vitamin C gummy (1007.2mg) was orally administered following a 12 hour fasting period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C gummy | Dietary Supplement | vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)] | Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)] | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
| Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)] | Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)] for All Study Participants | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
| Mean Plasma L-ascorbic Acid as Cmax | Mean Plasma L-ascorbic Acid as Cmax | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
| Mean Leukocyte L-ascorbic Acid as Cmax | Mean Leukocyte L-ascorbic Acid as Cmax | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Plasma Vitamin C Absorption Rate as Tmax | Mean Time of maximum Vitamin C concentration | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
| Mean Leucocyte Vitamin C Absorption Rate as Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annahita Ghassemi | Church & Dwight Company, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Church & Dwight Co., Inc. | Princeton | New Jersey | 08543 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31747355 | Derived | Evans M, Guthrie N, Zhang HK, Hooper W, Wong A, Ghassemi A. Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial. J Am Coll Nutr. 2020 Jul;39(5):422-431. doi: 10.1080/07315724.2019.1684398. Epub 2019 Nov 20. |
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Cross over study. Participants received each treatment at one of the two treatment visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin C Gummy, Then Vitamin C Caplet | The study consisted of two single-day study periods separated by a 7-day washout. At the first study day, a single oral dose of vitamin C gummy (1007.2mg) was orally administered following a 12 hour fasting period. After a 7 day washout period, a single oral dose of vitamin C caplet (1027.9mg) was orally administered following a 12 hour fasting period. |
| FG001 | Vitamin C Tablet, Then Vitamin C Gummy | The study consisted of two single-day study periods separated by a 7-day washout. At the first study day, a single oral dose of vitamin C caplet (1027.9mg) was orally administered following a 12 hour fasting period. After a 7 day washout period, a single oral dose of vitamin C gummy (1007.2mg) was orally administered following a 12 hour fasting period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cross over study. Participants randomly received one treatment at one of the two dosing days and the other treatment at the second dosing day.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)] | Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)] | Includes all Participants from treatment day 1, including those did not participate in treatment day 2. | Posted | Mean | Standard Deviation | μmol*min/L | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
|
Participants entered any AE's in a daily diary from the initiation of the study until 24 hours after the last oral dosing. Additionally, participants were asked about AE's at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin C Gummy | A single oral dose of gummy vitamin C to monitor vitamin C blood levels Vitamin C gummy: vitamin C |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Neutrophil Count | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annahita Ghassemi, PhD | Church & Dwight Co., Inc | 609-806-1200 | annahita.ghassemi@churchdwight.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2017 | Mar 31, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Vitamin C tablet | Dietary Supplement | vitamin C |
|
Mean Time of maximum Vitamin C concentration
| baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)] | Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 hours)] for All Study Participants | Includes all Participants from treatment day 1, including those did not participate in treatment day 2. | Posted | Mean | Standard Deviation | nmol*min/10^8 leukocytes | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
|
|
|
| Primary | Mean Plasma L-ascorbic Acid as Cmax | Mean Plasma L-ascorbic Acid as Cmax | Includes all Participants from treatment day 1, including that those did not participate in treatment day 2. | Posted | Mean | Standard Deviation | μmol/L | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
|
|
|
| Primary | Mean Leukocyte L-ascorbic Acid as Cmax | Mean Leukocyte L-ascorbic Acid as Cmax | Includes all Participants from treatment day 1, including those did not participate in treatment day 2. | Posted | Mean | Standard Deviation | nmol/10^8 leukocytes | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
|
|
|
| Secondary | Mean Plasma Vitamin C Absorption Rate as Tmax | Mean Time of maximum Vitamin C concentration | Includes all Participants from treatment day 1, including those did not participate in treatment day 2. | Posted | Mean | Standard Deviation | hours | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
|
|
|
| Secondary | Mean Leucocyte Vitamin C Absorption Rate as Tmax | Mean Time of maximum Vitamin C concentration | Includes all Participants from treatment day 1, including those did not participate in treatment day 2. | Posted | Mean | Standard Deviation | hours | baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours |
|
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|
| 0 |
| 35 |
| 0 |
| 35 |
| 2 |
| 32 |
| EG001 | Vitamin C Tablet | A single oral dose of tablet vitamin C to monitor vitamin C blood levels Vitamin C tablet: vitamin C | 0 | 35 | 0 | 35 | 1 | 33 |
| Mild Somnolence | General disorders | Systematic Assessment |
|
| Mild Nausea | Gastrointestinal disorders | Systematic Assessment |
|
Confidentiality and Master Service Agreement
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |